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VX-770 in People with CF and G551D Mutation - Open Label Safety Study (PERSIST)

Study Type:

Interventional

Intervention Category:

CFTR Modulation

Study Sponsor:

Vertex

Study Phase:

3

Recruitment Status:

Trial Completed

Study Drug(s):

Kalydeco

Number of Participants Being Recruited:

110

Single / Multi-Center:

Multi-Center

STUDY BACKGROUND INFORMATION:

Cystic Fibrosis (CF) is caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The CFTR protein is located on the cell membrane of the airways and sweat ducts. It is a chloride ion channel responsible for aiding in the regulation of salt and water absorption and secretion in tissues. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel. The increase in CFTR chloride ion channel opening may prevent hyperabsorption of water in the airway tissues, allowing for more favorable maintenance of airway hydration in people with CF.

This study will look at the long-term safety of VX-770 in people with CF and the G551D mutation. Subjects will receive VX-770 for 96 weeks during this study.

ELIGIBILITY

Age:

>= 6 Years

FEV1:

Not Applicable

P. aeruginosa status:

Not applicable

B. cepacia status:

Not applicable

Other Primary Eligibility Requirements:

To be included in this open-label extension study, a subject must have completed either VX-770-102 (STRIVE) or VX-770-103 (ENVISION).

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.

The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.